NCT05243199

Sacubitril/Valsartan for CKD5 Stage Dialysis Patients

Sacubitril/Valsartan for Dialysis Patients With CKD5 Stage Complicated With Hypertension- A Prospective, Randomized, Controlled Multicenter Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 330 (actual)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Hemodialysis or peritoneal dialysis CKD5 patients were randomly divided into Sacubitril/Valsartan and irbesartan treatment groups. Comparing the blood pressure, survival rates, the cardiac function, renal function,and adverse reactions of two groups, to evaluate whether the efficacy and safety of Sacubitril/Valsartan in the treatment of patients with CKD dialysis combined with heart failure is superior to that of irbesartan.

Conditions

• CKD5 Stage Dialysis
• Heart Failure

Interventions

Type	Name	Description
DRUG	Sacubitril/Valsartan	The initial dose of 50mg Qd was increased to 50mg Bid after 1 week and maintained to 100mg Bid after 2 weeks if the patient could tolerate it (no follow-up exit criteria were found).
DRUG	Irbesartan	The Initial dose of 75 mg Qd with sand, such as patients can tolerate and follow-up exit criteria (not appear, to 75 mg Bid to maintain after 1 week, 2 weeks can still be tolerance is raised to 150 mg Bid.

Timeline

• Start date: 2020-08-01
• Primary completion: 2023-03-01
• Completion: 2023-03-08
• First posted: 2022-02-16
• Last updated: 2023-03-17

Locations

1 site across 1 country: China